Lincoln Pharmaceuticals gets EU GMP nod for Khatraj manufacturing facility

Gujrat: Lincoln Pharmaceuticals Limited has received the European Union (EU) GMP certification from Germany FDA for its manufacturing facility located at Khatraj in Gujarat.

"The certification will allow the company to market its products in all the 27 member countries of the EU and also give access to the European Economic Area (EEA) countries. The company looks to enter the EU markets very soon with its dermatology, gastro and pain management products and gradually expand product portfolio", Lincoln said in its recent release

The inspection was done by the regulatory agency in December 2019 followed by final approval in May 2020. The company manufactures wide-range of drugs at its Khatraj facility and includes anti-infective, respiratory system, gynaecology, dermatology, gastro, pain management, cardio & CNS, anti-bacterial, anti-diabetic, anti-malaria among others.

Mr Mahendra Patel, Managing Director, Lincoln Pharmaceuticals Limited, said, "We are very pleased and excited to receive the EU GMP accreditation. This will be an important stepping stone in the journey of the company and will help to expand its presence in more regulated markets. The approval is valid for all three departments Tablet, Capsule and Cream & Ointment, which will cover a wide range of Pharmaceutical Formulation manufactured by the Company. EU GMP approval is the result of stringent quality and compliance norms followed at Lincoln Pharma across all departments especially the R&D and compliance. The certification will allow us to address the growing needs of patients in the EU markets and provide affordable and innovative medicines."

With the EU certification, the company will expand its business network to 90 plus countries. Company currently exports to 60 plus countries including East & West Africa, Central & Latin America and Southeast Asia and has got many product registrations in these countries and is also awarded a number of global tenders.

Export business has shown remarkable growth in the last few years. Exports have increased to 61% of total sales in FY20 from 11% of total sales in FY11.

Company has almost doubled the export turnover in FY20 as compared to FY18. Export of the company stood at Rs. 227 crores in FY 20 as compared to Rs. 197 crore in FY 19, a growth of 15% Y-O-Y.

"Over the years, the company has seen good traction in the export business, which is expected to get a further boost once EU operations begin. For the next phase of growth, the company is building a strong portfolio in lifestyle and chronic segment especially dermatology, gastro and pain management to complement its strong presence in the acute segment. Strategic growth initiatives, EU approval, new product approvals, better margin products along with operational efficiency are likely to contribute healthy growth and maximise value for all stakeholders in the near to medium term," said Mr Patel.

Read also: Lincoln Pharma gets Gujarat FDA approval to manufacture Hydroxychloroquine and Hydroxychloroquine Sulfate Tablets to fight COVID19